Back to resultsMindfulness Intervention for Overweight Primary Care Patients (MindEat)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TAU
TAU+MBHP
TAU+MB-EAT
Sponsored by
About this trial
This is an interventional other trial for Overweight focused on measuring Mindful Eating, Overweight, Primary Care, Randomized Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- women aged 18-59 years old, literate;
- Primary Care patients who have the body mass index (BMI) ≥25kgm2 and < 40kg/m2
- People who have an interest in the objectives of this study and consented to be randomized to one of three arms.
- Those who have participated in 75% of sessions or only two absences in the program
Exclusion Criteria:
- those who are under pharmacological treatment for overweight;
- pregnant women;
- those who have problems with substance use (drugs and alcohol);
- untreated hypothyroidism or hyperthyroidism;
- those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);
- current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);
- those who have undergone any type of Bariatric Surgery.
Sites / Locations
- Centro Mente Aberta de Mindfulness e Promoção de Saúde
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
TAU (treatment as usual)
TAU+MBHP
TAU+MB-EAT
Arm Description
The Treatment as Usual (TAU) will be considered as following: 1) In the cases of individuals presenting overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, primary care teams propose the improvement of the life style (more physically active, and with a better eating behaviour) in order to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²). 2) For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities (psycho-education), it is evaluated the need for individual dietary prescription by a nutritionist.
The Mindfulness-based Health Promotion (MBHP) developed by our research group (generic protocol) will be adapted from the Mindfulness-based Stress Reduction program (MBSR), It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems], which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice.
The Mindfulness-based Eating Awareness (MB-EAT) protocol consists in ten weekly sessions of 2,5 hour to improve compulsive eating, and to promote conscious eating.
Outcomes
Primary Outcome Measures
Feeding Behaviour
It is expected the improvement of the feeding behaviour measured by Dutch Eating Behaviour Questionaire (DEBQ) in total score and in 3 subscales: Restriction , External Intake and Emotional Intake and with the scale EAT 26
Secondary Outcome Measures
Fasting blood glucose
It is expected the improvement of Fasting blood glucose level
levels of mindfulness,
It expected to increase the levels of Mindfulness-psychometric scale
Levels of depression
It expected to reduce the levels of Depression-psychometric scale
Levels of anxiety
It expected to reduce the levels of anxiety -psychometric scale and serum cortisol
Serum cortisol
It expected to reduce the levels of cortisol
Self-compassion
It expected to improve the levels of self-compassion scale
HBA1C (glycated hemoglobina)
It is expected the improvement of glycated hemoglobina level
Insulin
It is expected reduction in insulin level
Full Information
NCT ID
NCT02893150
First Posted
August 29, 2016
Last Updated
October 7, 2021
Sponsor
Centro Mente Aberta de Mindfulness
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02893150
Brief Title
Mindfulness Intervention for Overweight Primary Care Patients
Acronym
MindEat
Official Title
Mindfulness as a Complementary Intervention for Overweight Primary Care Patients: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
December 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Mente Aberta de Mindfulness
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mindfulness has been applied in the United States and Europe to improve both physical and psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its lack, may also have particular relevance to obesity and eating disorders, reducing the episodes of "binge eating", which are partly responsible for weight regain for many people, and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process. The hypothesis is that Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a sustainable fashion, improve biochemical, psychometric and anthropometric parameters in primary care patients with overweight.
Detailed Description
A randomized-controlled trial will be conducted to compare treatment-as-usual (TAU) in Primary Care combined a generic MBI (with 8 sessions) developed by our research group, called "Mindfulness-Based Health Promotion" (MBHP) program versus TAU plus MB-EAT. It will be included women aged ≥18 and < 60, literate , with a BMI (body mass index) ≥ 25 kg/m2. The primary outcome is the improvement of the eating behaviour measured by DEBQ. Secondary outcomes are: It is expected improvement of nutritional status (reduction of body weight by at least 5% of the weight) along the intervention, as well as maintenance of this (without weight regain) which could lead to the prevention of multiple morbidities related to excess body weight. Will be assessed the levels of Mindfulness, stress, anxiety (psychometric scale and serum cortisol) and self-compassion. There will be performed basal (baseline), at post-intervention, 3 and 6 months follow-up measurements. The control group will receive the intervention that has been shown to be more effective at the end of the study (MBHP or MB-EAT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Mindful Eating, Overweight, Primary Care, Randomized Clinical Trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU (treatment as usual)
Arm Type
Active Comparator
Arm Description
The Treatment as Usual (TAU) will be considered as following: 1) In the cases of individuals presenting overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, primary care teams propose the improvement of the life style (more physically active, and with a better eating behaviour) in order to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²). 2) For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities (psycho-education), it is evaluated the need for individual dietary prescription by a nutritionist.
Arm Title
TAU+MBHP
Arm Type
Active Comparator
Arm Description
The Mindfulness-based Health Promotion (MBHP) developed by our research group (generic protocol) will be adapted from the Mindfulness-based Stress Reduction program (MBSR), It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems], which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice.
Arm Title
TAU+MB-EAT
Arm Type
Experimental
Arm Description
The Mindfulness-based Eating Awareness (MB-EAT) protocol consists in ten weekly sessions of 2,5 hour to improve compulsive eating, and to promote conscious eating.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
TAU (Treatment as Usual), individuals presenting with overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, teams of primary care (PC) organized care plans to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²).
For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities, evaluates the need for individual dietary prescription by the nutritionist. This decision is discussed among the team of PC and Matrix support team
Intervention Type
Behavioral
Intervention Name(s)
TAU+MBHP
Intervention Description
TAU (Treatment as Usual) + MBHP. We used a general (general vulnerability, not specific) mindfulness-based intervention (MBI) developed by our research group, an 8-week-group-based MBI called "Mindfulness-Based Health Promotion" (MBHP) program . It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems, which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice; more feasible to be implement in health services and facilities
Intervention Type
Behavioral
Intervention Name(s)
TAU+MB-EAT
Intervention Description
TAU (Treatment as Usual) + MB-EAT (mindfulness-based eating awareness training). Adapted from the MBSR, Mindfulness-based Eating Awareness Training (MB-EAT) or awareness training. This program was specially developed for the compulsive eating disorders and related problems[47]. In addition the four main techniques of meditation mentioned in the MBHP program includes modifications to these basic techniques, and include experimentation with different flavors, sweet and savory foods, etc. Has 10 weekly sessions of 2,5h
Primary Outcome Measure Information:
Title
Feeding Behaviour
Description
It is expected the improvement of the feeding behaviour measured by Dutch Eating Behaviour Questionaire (DEBQ) in total score and in 3 subscales: Restriction , External Intake and Emotional Intake and with the scale EAT 26
Time Frame
Up to 3-month of follow-up
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Description
It is expected the improvement of Fasting blood glucose level
Time Frame
Up to 3-month of follow-up
Title
levels of mindfulness,
Description
It expected to increase the levels of Mindfulness-psychometric scale
Time Frame
Up to 3-month of follow-up
Title
Levels of depression
Description
It expected to reduce the levels of Depression-psychometric scale
Time Frame
Up to 3-month of follow-up
Title
Levels of anxiety
Description
It expected to reduce the levels of anxiety -psychometric scale and serum cortisol
Time Frame
Up to 3-month of follow-up
Title
Serum cortisol
Description
It expected to reduce the levels of cortisol
Time Frame
Up to 3-month of follow-up
Title
Self-compassion
Description
It expected to improve the levels of self-compassion scale
Time Frame
Up to 3-month of follow-up
Title
HBA1C (glycated hemoglobina)
Description
It is expected the improvement of glycated hemoglobina level
Time Frame
Up to 3-month of follow-up
Title
Insulin
Description
It is expected reduction in insulin level
Time Frame
Up to 3-month of follow-up
Other Pre-specified Outcome Measures:
Title
Cholesterol and fractions, triglycerides
Description
It is expected reduction in cholesterol and fractions level and triglycerides
Time Frame
Up to 3-month of follow-up
Title
C-reactive protein
Description
It is expected reduction in PCR level
Time Frame
Up to 3-month of follow-up
Title
waist perimeter
Description
It is expected reduction in waist perimeter
Time Frame
Up to 3-month of follow-up
Title
food consumption
Description
It is expected improve quality of food consumption (questionaire)
Time Frame
Up to 3-month of follow-up
Title
Body fat
Description
It is expected to reduce the body fat percentage (bioimpedance)
Time Frame
Up to 3-month of follow-up
Title
Basal metabolism rate
Description
It is expected to increase the basal metabolic rate-calorimeter
Time Frame
Up to 3-month of follow-up
Title
Physical Activity
Description
It is expected to increase the physical activity (Brief Physical Activity Assessment Tool
Time Frame
Up to 3-month of follow-up
Title
Risk of eating Disorder
Description
It is expected to reduce the risk score of eating disorder (questionaire EAT 26)
Time Frame
Up to 3-month of follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women aged 18-59 years old, literate;
Primary Care patients who have the body mass index (BMI) ≥25kgm2 and < 40kg/m2
People who have an interest in the objectives of this study and consented to be randomized to one of three arms.
Those who have participated in 75% of sessions or only two absences in the program
Exclusion Criteria:
those who are under pharmacological treatment for overweight;
pregnant women;
those who have problems with substance use (drugs and alcohol);
untreated hypothyroidism or hyperthyroidism;
those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);
current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);
those who have undergone any type of Bariatric Surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Demarzo, MD, PhD
Organizational Affiliation
UNIFESP - Federal University of Sao Paulo, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Mente Aberta de Mindfulness e Promoção de Saúde
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness Intervention for Overweight Primary Care Patients
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